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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515959-38-00 | Other Identifier | EU Trial (CTIS) Number |
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Lack of Efficacy
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The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brensocatib 10 mg | Experimental | Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks. |
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| Brensocatib 40 mg | Experimental | Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks. |
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| Placebo Followed by Brensocatib 10 mg | Placebo Comparator | Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks. |
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| Placebo Followed by Brensocatib 40 mg | Placebo Comparator | Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib | Drug | Film-coated Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16 | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | Week 16 | |
| Percentage of Participants Achieving HiSCR75 at Week 16 | Week 16 | |
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Inclusion Criteria:
Exclusion Criteria:
Draining tunnel count of ≥20 at the Baseline Visit.
Surgical or laser intervention for an HS lesion during the Screening Period.
Clinical diagnosis of Papillon-Lefèvre Syndrome.
Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.
Participants having active liver disease or hepatic dysfunction.
Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
Received systemic (intravenous or orally [PO]) antibiotic therapy within 8 weeks before the Baseline Visit
a. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue.
Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
Received any immunomodulatory agents within 4 weeks before the Baseline Visit.
Note: Other Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Insmed Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Phoenix | Arizona | 85054-4502 | United States | ||
| USA007 |
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| Placebo | Drug | Film-coated Oral tablet |
|
| Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16 |
| Week 16 |
| Change From Baseline in Draining Tunnel Count at Week 16 | Baseline and Week 16 |
| Percentage of Participants Remaining Free from HS Flare by Week 16 | Week 16 |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | Baseline and Week 16 |
| Percentage of Participants Achieving IHS4-55 at Week 16 | Week 16 |
| Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16 | Baseline and Week 16 |
| Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3 | Week 16 |
| Number of Participants who Experienced at Least One Adverse Event (AE) | Up to Week 56 |
| Plasma Concentration of Brensocatib | Pre-dose and at multiple timepoints post-dose up to Week 56 |
| Sacramento |
| California |
| 95815 |
| United States |
| USA026 | Coral Gables | Florida | 33134 | United States |
| USA027 | Hollywood | Florida | 33024 | United States |
| USA021 | Margate | Florida | 33063 | United States |
| USA018 | Miami | Florida | 33125 | United States |
| USA025 | Ocala | Florida | 34470 | United States |
| USA004 | Tampa | Florida | 33613 | United States |
| USA010 | Weston | Florida | 33331 | United States |
| USA028 | Atlanta | Georgia | 30329 | United States |
| USA011 | Sandy Springs | Georgia | 30328 | United States |
| USA003 | Plainfield | Indiana | 46168 | United States |
| USA002 | Baton Rouge | Louisiana | 70809-2725 | United States |
| USA017 | Boston | Massachusetts | 02115 | United States |
| USA012 | Detroit | Michigan | 48201 | United States |
| USA024 | Fort Gratiot | Michigan | 48059 | United States |
| USA020 | Minneapolis | Minnesota | 55455 | United States |
| USA015 | St Louis | Missouri | 63104 | United States |
| USA013 | Lebanon | New Hampshire | 03766 | United States |
| USA009 | Cleveland | Ohio | 44106-1716 | United States |
| USA016 | Springfield | Ohio | 45505 | United States |
| USA019 | Hershey | Pennsylvania | 17033-2360 | United States |
| USA022 | Philadelphia | Pennsylvania | 19104-5127 | United States |
| USA005 | Dallas | Texas | 75230 | United States |
| USA023 | Dallas | Texas | 75231-6077 | United States |
| USA008 | Spokane | Washington | 99202 | United States |
| AUS003 | Darlinghurst | New South Wales | 2010 | Australia |
| AUS004 | Kogarah | New South Wales | 2217 | Australia |
| AUS001 | Brisbane | Queensland | 4151 | Australia |
| AUS006 | Woolloongabba | Queensland | 4102 | Australia |
| AUS002 | Fremantle | Western Australia | 6160 | Australia |
| BGR001 | Lovech | 5500 | Bulgaria |
| BGR003 | Pleven | 5800 | Bulgaria |
| BGR004 | Sofia | 1592 | Bulgaria |
| BGR002 | Stara Zagora | 6003 | Bulgaria |
| CAN003 | Barrie | Ontario | L4M 7G1 | Canada |
| CAN006 | Guelph | Ontario | N1L 0B7 | Canada |
| CAN007 | Peterborough | Ontario | K9J 5K2 | Canada |
| CAN011 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| CAN009 | Richmond Hill | Ontario | L4C 9M7 | Canada |
| CAN010 | Toronto | Ontario | M2N 3A6 | Canada |
| CAN004 | Québec | G1W 4R4 | Canada |
| FRA001 | Lyon | Auvergne-Rhône-Alpes | 69003 | France |
| FRA004 | Toulouse | Haute-Garonne | 31000 | France |
| FRA002 | Antony | 92160 | France |
| FRA003 | Paris | 75010 | France |
| FRA005 | Rouen | 76031 | France |
| DEU007 | Langenau | Baden-Wurttemberg | 89129 | Germany |
| DEU002 | Darmstadt | Hesse | 64283 | Germany |
| DEU001 | Bochum | North Rhine-Westphalia | 44791 | Germany |
| DEU003 | Dresden | Saxony | 1307 | Germany |
| DEU006 | Dessau-Roßlau | 6847 | Germany |
| DEU005 | Lübeck | 23538 | Germany |
| GRC002 | Athens | Attica | 106 79 | Greece |
| GRC004 | Chaïdári | Attica | 124 62 | Greece |
| GRC001 | N. Efkapria-Pavlos Melas | Thessaloniki | 56403 | Greece |
| GRC003 | Thessaloniki | 54643 | Greece |
| NLD001 | Rotterdam | 3015 GD | Netherlands |
| POL006 | Wroclaw | Lower Silesian Voivodeship | 51-685 | Poland |
| POL008 | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| POL002 | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| POL004 | Krakow | 30-727 | Poland |
| POL007 | Warsaw | 02-793 | Poland |
| POL001 | Warsaw | 02-962 | Poland |
| POL005 | Wroclaw | 50-450 | Poland |
| POL003 | Wroclaw | 50-566 | Poland |
| ESP006 | Badalona | Barcelona | 08916 | Spain |
| ESP004 | Las Palmas de Gran Canaria | Las Palmas Provincia | 35010 | Spain |
| ESP001 | Manises | Valencia | 46940 | Spain |
| ESP002 | Madrid | 28007 | Spain |
| ESP005 | Madrid | 28026 | Spain |
| ESP003 | Madrid | 28034 | Spain |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| C000619932 | brensocatib |
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